Dilated CardiomyopathiesNCT03527342
Sahlgrenska Cardiomyopathy Project
An observational study of Dilated Cardiomyopathies and Hypertrophic Cardiomyopathy, run by Göteborg University at 1 site in Sweden.
Trial summary
This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal. Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. The project will serve as: 1. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dilated Cardiomyopathies, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy
- How many people
- 3,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2018to Jan 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients are all patients referred to Sahlgrenska University Hospital, Gothenburg, Sweden with a cardiomyopathy diagnose.
Who may be able to join
- Patients with primary cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, myocarditis, giant cell myocarditis, sarcoidosis and amyloidosis engaging the heart
Who cannot join
- Patient with other preexisting cardiac diseases such as significant valvular, ischemic or pericardial disease before they receive a cardiomyopathy diagnose
- patients < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sahlgrenska University Hospital Cardiomyopathy Project: Mapping and Diagnosis of Cardiomyopathies to Enable Early and Specific Treatment
This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal.
Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. The project will serve as:
- resource for diagnostic and therapeutic trials
- common biomaterial bank
- resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results
- Conditions
- Dilated Cardiomyopathies, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Myocarditis, Sarcoidosis With Myocarditis
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Cardiomyopathy, Restrictive, Arrhythmogenic Right Ventricular Dysplasia, Myocarditis, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dilated Cardiomyopathy | Not described | |
| Myocarditis | Not described | |
| Sarcoidosis Heart | Not described | |
| Giant Cell Myocarditis | Not described | |
| Amyloidosis Heart | Not described | |
| Hypertrophic Cardiomyopathies | Not described | |
| Left Ventricular Myocardial Noncompaction Cardiomyopathy | Not described | |
| Arrhythmogenic Right Ventricular Cardiomyopathies | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression
Measured: 2018-2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jun 2018
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527342
- Sponsor's protocol ID
- SUCARD
- Status last verified
- Nov 2018
- First submitted
- 23 Apr 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sahlgrenska University Hospital Cardiomyopathy Project: Mapping and Diagnosis of Cardiomyopathies to Enable Early and Specific Treatment
- ClinicalTrials.gov ID
- NCT03527342
- Acronym / sponsor ID
- SUCARD
- Conditions
- Dilated Cardiomyopathies, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Myocarditis, Sarcoidosis With Myocarditis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal.
Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. The project will serve as:
- resource for diagnostic and therapeutic trials
- common biomaterial bank
- resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Dilated Cardiomyopathy | – | – |
| Myocarditis | – | – |
| Sarcoidosis Heart | – | – |
| Giant Cell Myocarditis | – | – |
| Amyloidosis Heart | – | – |
| Hypertrophic Cardiomyopathies | – | – |
| Left Ventricular Myocardial Noncompaction Cardiomyopathy | – | – |
| Arrhythmogenic Right Ventricular Cardiomyopathies | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are all patients referred to Sahlgrenska University Hospital, Gothenburg, Sweden with a cardiomyopathy diagnose.
Key inclusion criteria (1 listed)
- Patients with primary cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, myocarditis, giant cell myocarditis, sarcoidosis and amyloidosis engaging the heart
Key exclusion criteria (2 listed)
- Patient with other preexisting cardiac diseases such as significant valvular, ischemic or pericardial disease before they receive a cardiomyopathy diagnose
- patients < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to disease progression
Time frame: 2018-2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathies and Hypertrophic Cardiomyopathy, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression (time frame: 2018-2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.